Trial · NCT01229436
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
NCT01229436, Phase 3, Completed, Pfizer; results first posted 2014-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex). Trials, record NCT01229436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01229436
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
- NCT number
- NCT01229436
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 254 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Dupuytren's Contracture
- Interventions
- Xiapex
- First posted
- 2010-10-27
- Last updated
- 2014-03-17
- Results first posted
- 2014-03-17
- Limitations and caveats
Results were not reported for fifth injection as no finger received 5 injections.Results are reported for 'number of days of concomitant pain medication' as 'amount of pain medication' was interpreted as total number of days with pain medication use.
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Passive Extension Deficit (TPED) at Baseline for First Injection | Baseline for first injection | TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Baseline for Second Injection | Baseline for second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Baseline for Third Injection | Baseline for third injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection | Baseline for fourth injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Day 1 After First Injection | Day 1 after first injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Day 7 After First Injection | Day 7 after first injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Day 30 After First Injection | Day 30 after first injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Day 1 After Second Injection | Day 1 after second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Day 7 After Second Injection | Day 7 after second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
| Primary | Total Passive Extension Deficit (TPED) at Day 30 After Second Injection | Day 30 after second injection | TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Passive Extension Deficit (TPED) at Baseline for First Injection | Baseline for first injection | Full analysis set(FAS):participants who received at least (\>=)1 injection of Xiapex,had \>=1 post-injection efficacy assessment(goniometric/participant-reported). 'N'(number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection | FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points. | degrees | MEDIAN |
| SECONDARY | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection | FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points. | participants | NUMBER |
| SECONDARY | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection | FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points. | participants | NUMBER |
| SECONDARY | Number of Participants With Type of Concomitant Pain Medication Used | Screening up to Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Screening up to Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Laboratory Abnormalities | Screening up to Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. | participants | NUMBER |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group631
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Passive Extension Deficit (TPED) at Baseline for First Injection | Xiapex | 55.0 | Full Range 2 to 180 | degrees | |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Baseline for first injection: MP Joint (n=211) | 40.0 | Full Range 0 to 90 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Day 1 after first injection: MP Joint (n=207) | 8.0 | Full Range 0 to 80 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Day 7 after first injection: MP Joint (n=209) | 0.0 | Full Range 0 to 82 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Day 30 after first injection: MP Joint (n=209) | 0.0 | Full Range 0 to 70 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Baseline for second injection: MP Joint (n=33) | 25.0 | Full Range 0 to 74 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Day 1 after second injection: MP Joint (n=33) | 5.0 | Full Range 0 to 45 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Day 7 after second injection: MP Joint (n=33) | 5.0 | Full Range 0 to 50 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Day 30 after second injection: MP Joint (n=32) | 8.5 | Full Range 0 to 30 | degrees |
| Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Xiapex | Baseline for third injection: MP Joint (n=9) | 20.0 | Full Range 0 to 50 | degrees |
1 to 10 of 631Source ClinicalTrials.gov
See all 631 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xiapex | 254 | |
| Overall Study | COMPLETED | Xiapex | 249 | |
| Overall Study | NOT COMPLETED | Xiapex | 5 |
Source ClinicalTrials.gov
Adverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Xiapex | 17 | 254 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Xiapex | 6 | 254 | |
| other | Oedema Peripheral | General disorders | Xiapex | 111 | 254 | |
| other | Injection Site Pain | General disorders | Xiapex | 53 | 254 | |
| other | Injection Site Haematoma | General disorders | Xiapex | 39 | 254 | |
| other | Injection Site Swelling | General disorders | Xiapex | 23 | 254 | |
| other | Injection Site Oedema | General disorders | Xiapex | 20 | 254 | |
| other | Tenderness | General disorders | Xiapex | 15 | 254 | |
| other | Axillary Pain | General disorders | Xiapex | 10 | 254 | |
| other | Injection Site Vesicles | General disorders | Xiapex | 10 | 254 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xiapex | ||
| Total, other adverse events | Xiapex | 212 | 254 |
| Total, serious adverse events | Xiapex | 12 | 254 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24470559 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01229436
GET https://conductscience.org/api/trials/v1/NCT01229436/registered?page=2